FDA approves first interchangeable biosimilar insulin product

The Food and Drug Administration this week approved the first interchangeable biosimilar insulin product to treat diabetes. The product (Semglee) can be substituted for the previously approved biological insulin product Lantus to treat type 1 diabetes in children and type 1 or 2 diabetes in adults.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, M.D. 
 
For more information on biosimilar and interchangeable products, see the new FDA resources for health care providers.